Masking procedure, randomization and stratification, and compliance monitoring in the Growth Failure in Children with Renal Diseases Study.
Ensuring the integrity of a study such as the GFRD Study requires close cooperation among all groups involved with the study and the patient. Many factors may influence the outcome and validity of a multicenter, double-masked, randomized trial. Any dosage modifications that may need to be made rely totally on established communication between the centers, the DCC, and the Core Pharmacy. When the procedures outlined above are followed, masking is ensured and patient compliance can be measured.
Shasky
D A
DA
Medical College of Virginia, Health Sciences Division of Virginia Commonwealth University, Richmond 23298.
Coppedge
S H
SH
Boyle
R M
RM
Chan
J C
JC
D002117:Calcitriol / Q000627:therapeutic use*; D002648:Child; D004097:Dihydrotachysterol / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006130:Growth Disorders / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications / Q000188:drug therapy*; D010349:Patient Compliance; D016032:Randomized Controlled Trials as Topic / Q000379:methods*
D002117:Calcitriol; D004097:Dihydrotachysterol